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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 May 2019 |
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Main ID: |
ISRCTN62219234 |
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Date of registration:
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27/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Changing illness perceptions: a randomised controlled trial of a psychological, family-based intervention to improve outcomes in type 2 diabetes
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Scientific title:
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Changing illness perceptions: a randomised controlled trial of a psychological, family-based intervention to improve outcomes in type 2 diabetes |
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Date of first enrolment:
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01/04/2006 |
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Target sample size:
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122 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62219234 |
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Study type:
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Interventional |
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Study design:
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This study is a randomised controlled trial with an intervention group and a control group. (Not Specified)
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Phase:
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Not Specified
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Susan
Smith |
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Address:
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Department of Public Health and Primary Care
Trinity Centre for Health Sciences
AMiNCH
Tallaght
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Dublin 24
Ireland |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Have type 2 diabetes for more than one year, and at least two out of their last three HbA1c readings have been 8.0% or over, in order to identify patients with persistent poor control
2. Over 18 years of age
3. Have fluency in English
Exclusion criteria: Patients with a significant mental or physical illness, as determined by the patients? clinician, will be excluded. ?Significant mental or physical illness ?is defined as any illness that is thought likely to impair the patient?s capacity to change their lifestyle behaviour or assimilate new information.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes
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Intervention(s)
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The study is a psychological intervention, designed to change peoples? cognitions about their diabetes, with a view to improving diabetes self-management behaviours, and ultimately diabetes outcomes. The intervention is aimed at changing any negative or misperceptions about diabetes, and improving, in a positive direction, the degree of similarity between patient and family members? cognitions in relation to diabetes.
The intervention will be delivered by a health psychologist who is trained in using motivational interviewing techniques. The intervention also incorporates a family member of the person with diabetes, and will also focus on the family members? cognitions about diabetes. The participants in the control group receive the usual care.
The intervention will be delivered over three sessions, one session a week. Participants will be followed up at 6 months from time of randomisation.
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Primary Outcome(s)
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Primary outcomes will be collected at baseline and at 6-month follow up.
1. HbA1c
2. Illness perceptions
3. Psychological well-being
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Secondary Outcome(s)
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Secondary measures will be collected at baseline and at 6-month follow up.
1. Biomedical outcomes
a. Blood pressure
b. Body mass index
c. Cholesterol
2. Diabetes self-efficacy
3. Social support
4. Daily activities
5. Self-care activities
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Secondary ID(s)
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RP/2005/178
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Source(s) of Monetary Support
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Health Research Board, Research Project Grant - General 2005 (RP/2005/178) (Ireland)
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Ethics review
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Status:
Approval date:
Contact:
The Joint Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals, approved on the 8th February 2006.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/03/2009 |
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URL:
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